Werkzaamheden

Works within the site Data Integrity project for process automation and IT systems. Implements changes to system documentation following the analysis of data integrity gap assessments. Executes and reports periodic reviews of process automation and IT systems according to predefined processes. Works with the DI SME to offer guidance regarding data integrity gap remediation actions to the Business and Technical System Owners.

Principal responsibilities - Write and revise system SOP’s / systems administration SOP’s etc… to include data integrity requirements - Analyse data integrity gap analysis results, propose and execute remediation actions - Guides Business and Technical System Owners in current expectation of Data Integrity - Understands both technical and procedural requirements of Data Integrity in a production system / PLC / HMI / SCADA / MES environment - Manages work according to a schedule

The focus of the function is to execute remediation actions that ensure that the Computerized Quality Systems meet the current requirements of Data Integrity. The complexity lies also in the fact that position operates in a complex, multi-functional, and sometimes multi-site environment, where continuous improvement of the Computerized Quality Systems is required. The position requires a strong analytical and independent thinking and decision making to find structural, regulatory, and business wise sound solutions.

Vereisten

- Minimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience during work life. - Pharmaceutical or related industry work experience for 2-4 years, of which a substantial part in Computerized Systems and related functions. - Experience in a complex, multinational work environment/company. - Project management skills and interpersonal skills, engaged in contact with personnel at all levels within the organization. - Written and oral communication skills in English. Dutch is preferable. - Self-starter, planning skills, and ability to prioritize multiple commitments. - Analytical thinking and (technical) problem solving. - Pro Active, works independently, takes actions in the absence of specific instruction - Excellent communication and advisory skills, result oriented.